Organ transplantation represents the preparation and harvesting of an organ from a donor or a donor site (if the donor and recipient are the same), and the implantation, maintenance and/or use of the organ into or by the recipient of the donated organ. It has been estimated that there are more than 50,000 organ transplants performed per year in the major healthcare markets (e.g., U.S., Europe and Japan), and that there are more than 170,000 patients on waiting lists for organ transplants. Demand for healthy organs significantly outstrips the supply.
A major challenge in organ transplantation has been transplant rejection, which can lead to significant complications in organ function or to transplant failure. In general, this has been addressed through the matching of donors and recipients who have highly similar serotypes, and through the use of immunosuppressive drugs to manage the immunological response underlying transplant rejection.
Another major challenge has been preservation of organ viability prior to and during the implantation procedure. The removal, storage and transplantation of an organ may profoundly affect the internal structure and function of the organ and can influence significantly the degree to which the return of normal organ function is delayed or prevented after transplantation is completed. Such organ injury occurs primarily as a result of ischemia and hypothermia, but may also be related to reperfusion of the organ ex vivo or during implantation. Techniques for organ preservation, including ex vivo perfusion, serve to minimize this damage to promote optimal graft survival and function. But, even with these techniques, the organ health will decline is many cases, affecting transplantation outcome, and in some cases, the decline is so significant that the donated organs are rejected prior to transplantation as non-viable.
A technology that addresses these important challenges in organ transplantation should have a substantial impact on patient quality of life and survival, and on the treatment of the complications associated with transplantation.